operational guideline for chinese medicine research 醫院管理局

Hospital Authority Head Office Document No. HAHO-CC -GL-CMD-002-v04

Issue Date

10/12/2019

Operational Guideline for Chinese Medicine Research

醫院管理局中醫科研指引

Review Date 10/12/2022

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This printed copy may not be the most updated version. Please refer to the electronic version for confirmation i f in doubt.

醫院管理局

中醫科研指引

Operational Guideline for

Chinese Medicine Research

Version Effective Date

1.0 16/07/2013

2.0 19/01/2016

3.0 09/01/2017

4.0 10/12/2019

Document Number HAHO-CC-GL-CMD-002-v04

Author Chinese Medicine Department, HAHO

Custodian Chief (Chinese Medicine Department), HAHO

Approved/ Endorsed By Committee on Chinese Medicine

Approval Date 10/12/2019

Distribution List C(CM), CMD, BSS, CPO, CRWG, CMCTRs


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Content

1. Purpose....................................................................................................... 3

2. Background................................................................................................. 3

3. Objective ..................................................................................................... 3

4. Governance Structure ................................................................................ 4

4.1 Central Research Working Group .......................................................... 5

4.2 Expert Panel ............................................................................................ 6

5. Application and Vetting Procedures, and Research Monitoring

Mechanism ........................................................................................................... 7

5.1 Type I: Research Projects Funded by HACMD ..................................... 7

5.2 Type II: Research Projects Funded by CMCTR(s) .............................. 12

5.3 Type III: Research Projects in CMCTRs Funded from Other Sources16

6. Other Relevant Guidelines ....................................................................... 19

Appendices

I. HA Tripartite Clinic Indication of Interests for Research Form

II. (a) Chinese Medicine Research Application Form (For Clinical Research)

(b) Chinese Medicine Research Application Form (For Systematic Review)

III. Template of Chinese Medicine Research Monitoring Report


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1. Purpose

This operational guideline provides the application procedure and monitoring

mechanism for the application of Chinese medicine (CM) research projects in

Hospital Authority Chinese Medicine Department (HACMD) and the Chinese

Medicine Centres for Training and Research (CMCTRs).

2. Background

In accordance with Government’s direction set out in 2000 Policy Address to provide

out-patient CM services in the public sector, the Hospital Authority (HA) Board has

endorsed the development of an evidence-based CM (EBCM) service model. The HA

was subsequently tasked to set up 18 CMCTRs operated on a tripartite collaboration

model involving the HA, a non-governmental organization (“NGO”) and a local

university, with the NGOs as the operators of CMCTRs, to deliver the EBCM service.

The CMCTRs not only provide CM services, but also a platform for training and

research to the Chinese medicine practitioners (CMPs).

To better steer and govern the EBCM development, HACMD has established the

(a) Central Research Working Group (CRWG) for setting thematic priorities; and

(b) Expert Panel for providing opinion in the research planning.

3. Objective

To provide guidance on the application procedure and monitoring mechanism for the

CM research projects administered by HACMD.


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4. Governance Structure

HACMD has established CRWG under the Committee on Chinese Medicine (C(CM))

and the Expert Panel under CRWG. Issues regarding CM research and training will

be discussed in CRWG and the resolutions will be reviewed and endorsed in C(CM).

HACMD provides administration support for C(CM) and reports to senior

management of HA, e.g. Director of Cluster Services (D(CS)), Directors’ Meeting (Ds’

Meeting), Medical Services Development Committee (MSDC) and Administrative and

Operational Meeting (AOM) or HA Board, if necessary.

Diagram of the governance structure

Ds’ Meeting

HACMD C(CM)

CRWG

Expert Panel

D(CS)

MSDC

AOM/HA Board


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4.1 Central Research Working Group

4.1.1 Objective

To facilitate CM research according to the development directions of CMCTRs, and to

advise on the development of CM research monitoring and training by HACMD.

4.1.2 Composition of Membership

Chairman: Chief (Chinese Medicine Department)

Secretary: 1 Representative from HACMD

Members: 1 Representative from HA Head Office (HAHO)

3 Representatives from local universities

3 Representatives from NGOs

2 Chinese medicine practitioners from the private sector

4.1.3 Terms of Reference

a. To advise the strategic direction and thematic priorities in CM research and

training.

b. To advise in setting up appropriate monitoring mechanism, collaborative platform

and training modules in research.

4.1.4 Frequency of Meeting

Yearly (at least once per year)

4.1.5 Tenure

2 years


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4.2 Expert Panel

4.2.1 Composition of Membership

Experts in specific research areas.

4.2.2 Terms of Reference

a. To review scientific merit, feasibility and desirability.

b. To make recommendations on research proposals.

4.2.3 Frequency of Meeting

Ad-hoc

4.2.4 Tenure

2 years


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5. Application and Vetting Procedures, and Research Monitoring Mechanism

According to the funding source, there are three types of research projects:

Type I: Research projects funded by HACMD

Type II: Research projects funded by CMCTR(s)

Type III: Research projects in CMCTR(s) funded from other sources

The respective application and vetting procedures, and research monitoring

mechanism established according to the type of research project are as follows:-

5.1 Type I: Research Projects Funded by HACMD

Type I projects refer to research projects funded by HACMD.

5.1.1 Application Procedures

a. HACMD announces the endorsed thematic priorities and prepares the

specifications accordingly. HACMD may seek professional input from the Expert

Panel where necessary.

b. HA Business Support Services Department (BSSD) issues tender/ quotation

invitation with the specifications.

c. Principal Investigator (PI) submits application to BSSD according to the

specifications.

i) If the research is to be collaborated with CMCTR(s), PI should liaise with the

CMCTR(s) to complete the HA Tripartite Clinic Indication of Interests for

Research Form (Appendix I).

ii) Application documents should include the followings:

- Research proposal (please refer to Guidelines for Good Clinical Practice in

Clinical Research on Chinese Medicine (Lo & Ko, 2001) for the content of

a research protocol);

- Curriculum vitae of PI;

- HA Tripartite Clinic Indication of Interests for Research Form signed by

CMCTR(s) (if the project is to be collaborated with CMCTR(s));

- Approval letter of Research Ethics Committee (REC) when available, if

necessary.


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5.1.2 Vetting Procedures

a. Member(s) of Expert Panel will be invited to be part of the Assessment Panel (AP)

for the review of applications according to assessment criteria.

b. After the review of applications by AP, HACMD submits the results to BSSD for

further approval in accordance with HA procurement procedure.

c. BSSD informs successful applicant(s) for the accepted application(s). Applicants

who do not receive any notification after the validity period as stated in the

invitation may assume their applications unsuccessful.

d. PI attends preparatory meeting convened by HACMD and finalizes the proposal.

e. PI seeks REC approval in parallel, if necessary.

f. 1st payment is arranged to PI.

g. PI submits REC approval letter, if necessary, to HACMD.

h. PI commences the research project. If the project is collaborated with CMCTR(s),

PI shall submit the research proposal to the relevant Operation & Risk

management Sub-committee (O&RM) for discussion and seek endorsement from

the corresponding Centre Management Committee(s) (CMC) of the CMCTR(s).

i. HACMD informs members of CRWG and C(CM) of the award results.

5.1.3 Research Monitoring Mechanism

a. PI commences the research project.

b. HACMD convenes quarterly monitoring meetings. PI shall attend the meetings

and submit quarterly progress reports (Appendix III).

i) The quarterly report should be submitted 1 week before the quarterly research

monitoring meeting.

ii) The quarterly report should include the progress of the project, incidents if any,

encountered difficulties and identified areas where the PI may need support or

advice from HACMD.

5.1.4 Project Completion

a. PI submits final report and complete all deliverables stated in the contract.

i) The final report should be submitted within 30 days of the project end date. It

must be concise and provide HACMD with sufficient information to evaluate

the project completeness. It should comprise of the following:

- An abstract written in a style similar to a journal article

- Main body of the report; it should be written in a style similar to that of a

journal article. Submitted reports should be on par with those submitted to

refereed journals


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- Copy of manuscript(s) and/ or abstract submitted to particular journal(s)

and/ or conference(s)

- All raw data of the project

- Official financial statement of the project

ii) The content of report should contain sufficient information for HACMD to

assess whether the work has been carried out in accordance with the

approved proposal and evaluate the quality of the research output. PI is

obliged to revise the report according to the feedback of HACMD, if any, and

submit their response in compliance with the deadlines specified by HACMD.

iii) PI is encouraged to submit the manuscript to an international journal for

publication.

b. HACMD arranges final payment to the PI after all the deliverables have been

completed in accordance with the terms and conditions of the contract and to the

satisfaction of the HA.

5.1.5 Actions for Non-Compliance

If the PI cannot fulfil the requirements and complete the deliverables stated in the

contract, attend the monitoring meetings, submit/ revise the quarterly and final

reports as required, HA shall request PI to provide explanations as well as

remedial actions through quarterly meetings or via email. Should non-compliance

continues, HACMD shall issue written letter and reserve the right to:

a. withhold the final payment;

b. terminate the project; and

c. arrange refund from the PI for the payment made, if necessary.


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5.1.6 Flowcharts for Type I Projects

a. Flowchart of Application and Vetting Procedures

Yes

HACMD announces the endorsed

thematic priorities

Yes

AP reviews the application

PI submits application to BSSD

Unsuccessful

application

PI attends preparatory meeting

and finalizes proposal

Yes

No

HA approves the application

HACMD reports at CRWG

HACMD prepares specifications and issues

tender/ quotation invitation via BSSD

PI submits application to REC

(if necessary)

Application is approved by REC

No

HACMD arranges 1st payment

PI commences the

research project

HACMD reports at C(CM)

No

if collaborated with CMCTR(s),

PI submits research proposal to O&RM for discussion

and seeks corresponding CMC endorsement

()


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b. Flowchart of Research Monitoring Mechanism

Yes

No

PI commences the research project

PI attends quarterly monitoring meetings

and submits quarterly reports 1 week

in advance

Completion of data

collection & analysis



Final payment to PI

No

Yes

PI submits final report

HACMD received

all deliverables

(Project completion)

PI returns all raw data and

official financial statement

PI prepares manuscript(s)

and/ or abstract(s)

PI acknowledges HACMD

PI submits for publication

and/ or to conference


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5.2 Type II: Research Projects Funded by CMCTR(s)

Type II projects refer to research projects funded by CMCTR(s), including projects

utilizing manpower support provided by CMCTR(s).


a. HACMD announces the endorsed thematic priorities.

b. PI initiates and drafts research proposal according to the thematic priorities.

c. PI liaises with the CMCTR(s) for collaboration and completes the HA Tripartite

Clinic Indication of Interests for Research Form (Appendix I).

d. PI submits application to HACMD.

i) PI should seek REC approval in parallel, if necessary.

ii) Application documents should include the followings:

- Application form (Appendix II(a) for clinical research; Appendix II(b) for

systematic review);


Clinical Research on Chinese Medicine (Lo & Ko, 2001) for the content of a

research protocol);



CMCTR(s);

- Approval letter of REC when available, if necessary.


a. HACMD collects the applications and verifies CMCTR’s reason to support the

research project which is relevant to the development direction of the CMCTR.

CMCTRs shall seek CRWG approval via HACMD for collaborating projects

outside thematic priorities.

b. HACMD sends the applications to the Expert Panel.

c. Expert Panel reviews the applications

d. HACMD informs PI and CMCTR(s) of the recommendations of Expert Panel.

e. PI submits REC approval letter to HACMD, if necessary.

f. PI submits the research proposal to the relevant O&RM and CMC of the

CMCTR(s) for discussion and endorsement respectively. PI attends and presents

the proposal at the meetings.

g. After obtaining CMC endorsement, PI attends preparatory meeting convened by

HACMD and finalizes the proposal.


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h. For projects where funding will be released from CMCTR(s) to the collaborating

institution, e.g. university, a research collaboration agreement (including but not

limited to funding sources, research indemnity, intellectual property, confidentiality,

etc) shall be signed between the supporting CMCTR(s) and the collaborating

institution. The study results shall be jointly owned by the collaborating institution,

supporting CMCTR(s) and HA.

i. CMCTR(s) arrange 1st payment to PI and PI commences the research project.

j. HACMD informs members of CRWG and C(CM) of the award results.



b. HACMD convenes quarterly monitoring meetings. PI shall attend the meetings

and submit quarterly progress reports. For the requirement of the reports, please

refer to Section 5.1.3b.

c. PI shall also report the progress at O&RM and/or CMC meetings if required.


a. PI submits final report and completes all deliverables stated in the proposal and

agreement. For the requirement of the final report, please refer to Section 5.1.4a.

b. HACMD confirms completion of all deliverables and informs CMCTR(s).

c. PI reports the research findings at O&RM and CMC of the CMCTR(s).

d. CMC approves project completion and CMCTR(s) arrange final payment after all

the deliverables have been completed in accordance with the agreement.

5.2.5 Actions for Non-Compliance

If the PI cannot fulfil the requirements and complete the deliverables stated in the

proposal and agreement, attend the monitoring meetings, submit/ revise the quarterly

and final reports as required, HA shall request PI to provide explanations as well as

remedial actions through quarterly meetings or via email. Should non-compliance

continues, HACMD/ CMCTR(s) shall issue written letter and reserve the right to:

a. withhold the final payment;

b. terminate the project; and

c. arrange refund from the PI for the payment made, if necessary.


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5.2.6 Flowcharts for Type II Projects


CRWG approves the collaboration (for projects

outside thematic priorities) & the project is relevant to CMCTR’s

development direction

PI submits application with CMCTR(s)’ Indication of Interests for Research

PI attends preparatory meeting

and finalizes proposal

No

No

PI submits application to REC (if necessary)

Application is approved by REC

Yes

Expert Panel recommends the application after

review

Unsuccessful application

PI signs collaboration agreement with CMCTR (funded projects)

Yes

No

Application is discussed in O&RM and

endorsed by CMC


CMCTR arranges 1st payment (funded projects)

Yes

PI commences the

research project

HACMD announces the endorsed

thematic priorities


PI prepares research proposal and liaise

with CMCTR(s) for collaboration

No

Yes


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Approved by CMC



Final payment to PI

(funded projects)


PI attends quarterly monitoring meetings and

submits quarterly report 1 week

in advance

Completion of data

collection & analysis

Yes

No

PI prepares manuscript(s)

and/ or abstract(s)

PI submits final report

HACMD received

all deliverables

(Project completion)

Yes

No

PI acknowledges HACMD &

supporting organization(s)

PI submits for publication

and/ or to conference

PI returns all raw data and

official financial statement

Recommended by O&RM


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5.3 Type III: Research Projects in CMCTRs Funded from Other Sources

Type III projects refer to research projects with no research funding and manpower

support from HACMD/ CMCTR(s).


a. PI seeks collaboration for an endorsed/ funded research proposal with REC

approval, if necessary.

b. PI liaises with the CMCTR(s) for collaboration and completes the HA Tripartite

Clinic Indication of Interests for Research Form (Appendix I). CMCTRs should

consider the collaboration under the circumstance that the collaboration should

have minimal influence on the daily operation of the CMCTR.

c. PI submits application to HACMD with the REC approval, if necessary.

i) Application documents should include the followings:

- Application form (Appendix II(a) for clinical research; Appendix II(b) for

systematic review);


Clinical Research on Chinese Medicine (Lo & Ko, 2001) for the content of a

research protocol);



CMCTR(s);

- Approval letter of REC, if necessary.


a. HACMD collects the application and verifies CMCTR’s reason to support the

research project. The collaboration should have minimal influence on the daily

operation of the CMCTR.

b. HACMD sends the application to the Expert Panel.

c. Expert Panel reviews the application.

d. HACMD informs PI and CMCTR(s) of the recommendations of Expert Panel.

e. PI submits the research proposal to the relevant O&RM and CMC of the

CMCTR(s) for discussion and endorsement. PI attends and presents the

proposal at the meetings.

f. After obtaining CMC endorsement, PI commences the research project.

g. HACMD informs members of CRWG and C(CM) of the endorsement.


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b. On behalf of the CMCTR, Chinese Medicine Chief of Service (CMCOS) is

responsible to monitor the progress of the research. PI should report regularly to

CMCOS as required. PI should also report to O&RM and/ or CMC if required.


PI should prepare project summary within 2 months upon project completion and

submit to O&RM and CMC via CMCOS. PI should also report to O&RM and/ or CMC

if required.


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5.3.5 Flowcharts for Type III Projects




PI reports research progress to CMCOS

Project completion

PI submits project summary and reports

at O&RM and/ or CMC if required

No

Yes


No

Yes

Expert Panel recommends the application after

review

PI submits application with CMCTR(s)’ Indication of Interests for Research

and REC approval, if necessary

Unsuccessful

application


No

Yes

Application is discussed in O&RM and

endorsed by CMC


HACMD verifies CMCTR’s reason to support the research project


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6. Other Relevant Guidelines

6.1 Hospital Authority. (2010). Clinical Research Management and Compliance

at Study Sites.

Retrieved from

http://cetm.home/ces/re/HA-Policy-Guidelines/Guiding-Handbook/files/HA_Handboo

k_2nd-Ed_Final151016(Updated)-with-Cover.aspx

6.2 Lo, S. V., & Ko, W. M. (2001). Guidelines for Good Clinical Practice in

Clinical Research on Chinese Medicine. Retrieved from Hospital Authority,

e-Knowledge Gateway (eKG) website (intranet):

https://www.ekg.org.hk/hacg/haonly/CM_hacg/CM_GuidelinesForGoodClinicalPracti

ceInClinicalResearchOnCM_eng.pdf

Enquiries

Please contact HACMD ([email protected]) for any enquiries concerning the

content of this operational guideline.

http://cetm.home/ces/re/HA-Policy-Guidelines/Guiding-Handbook/files/HA_Handbook_2nd-Ed_Final151016(Updated)-with-Cover.aspx

http://cetm.home/ces/re/HA-Policy-Guidelines/Guiding-Handbook/files/HA_Handbook_2nd-Ed_Final151016(Updated)-with-Cover.aspx

https://www.ekg.org.hk/hacg/haonly/CM_hacg/CM_GuidelinesForGoodClinicalPracticeInClinicalResearchOnCM_eng.pdf

https://www.ekg.org.hk/hacg/haonly/CM_hacg/CM_GuidelinesForGoodClinicalPracticeInClinicalResearchOnCM_eng.pdf

20

Please refer to http://cmk.ha.org.hk/ for the most updated version

Appendix I

HA Tripartite Clinic Indication of Interests

for Research

To: Secretariat

Hospital Authority Chinese Medicine Central Research Working Group

Email: [email protected]

Fax: 2338 5189

We *are / are not interested to support *with / without financial and/or manpower

indications to the following project :

Project Title

Principal Investigator

Institution

Reason to Support

(Example: relevant to the development

direction of the CMCTR, e.g. cancer)

* Please delete where inapplicable

Name : __________________

Post Title : __________________

For and On Behalf of HA Tripartite Clinic : __________________

Signature : ___________________

Date : ___________________

http://cmk.ha.org.hk/

mailto:[email protected]

21

Central Research Working Group


Application Form (For Clinical Research)

PART I: OUTLINE OF APPLICATION

1. Name of Study

1.1 Scientific Title (should include study design, name of intervention, condition being

studied and study outcomes):

1.2 Short Title (for easy quote):

1.3 Is this application for continuation of a project already started?

Yes (Please specify: ______________ ) ; No

1.4 Have you applied to other bodies for financial support towards this project?


1.5 Have you applied to research ethics committee for approval?


2. Applicant (Principal Investigator)

2.1 Title: Surname: First Name:

Name in Chinese:

University Staff Position:

Department/ University:

HA Staff Position:

Department/ Hospital:

NGO Staff Position:

NGO:


Appendix II(a)


22

2.2 Qualifications and relevant experience (<500 words)

23

2.3 Phone number:

2.4 Fax number:

2.5 E-mail:

2.6 Mailing address:

3. Co-investigators

Title Surname First Name Post Relevant

Qualifications

Department Institution

4. Study Site(s)

4.1 Is this a multi-centered trial? Yes No

4.2 Please indicate your study site(s) in HA cluster and/ or CMCTR.

5. Milestones

5.1 Proposed study start date: (mm/yyyy)

5.2 Proposed study end date: (mm/yyyy)

24

6. Brief Summary of Study (<1000 words)

25

7. Major Ethical Issues (<500words)

26

PART II: STUDY DETAILS

8. Scientific basis

8.1 Disease group (choose from the thematic priorities):

8.2 Background, current evidence and key references:

8.3 Aim of study:

8.4 Hypothesis (for quantitative studies only):

8.5 Intervention, if applicable:

8.6 Study design:

8.7 Methodology:

8.8 Methods of analysis:

27

8.9 Primary outcome,

if applicable

8.10 Secondary outcome(s),

if applicable

9. Study subjects

9.1 Inclusion criteria:

9.2 Exclusion criteria:

9.3 Sample-size and rationale for calculation:

Sample size =

based on the following rationale:

9.4 How will subjects be identified and recruited?

10. Anticipated Benefits to Study Subjects

Outcome measure(s) Time-point

28

PART III: BUDGET AND USE OF RESOURCES

11. Source of Funding

11.1 NGO: Yes (Please specify: ______________ ) ; No

11.2 University: Yes (Please specify: ______________ ) ; No

11.3 Government: Yes (Please specify: ______________ ) ; No

11.4 Others: Yes (Please specify: ______________ ) ; No

11.5 Amount requested: HKD______________

Staff Cost

Equipment

Others (Please Specify)

Admin Overhead

Total

12. Resources Implication and Conflict of Interest

12.1 Will this study use HA / CMCTR resources? Yes No

12.1.1 If yes, provide details:

12.2 Will study site receive reimbursement for the study? Yes No


12.3 Is there a non-monetary (drug, consumable or equipment) sponsorship?

Yes No


13. Financial Costs and Payment to Subjects

13.1 Will the subjects be charged for the study? Yes (Please specify: ______) ;

No

13.2 Will subjects receive payment? Yes (Please specify: ______) ;

No

29

14. Research Indemnity and Clinical Trial Certificate

14.1 Will a clinical trial certificate be applied? Yes (Please specify: _______) ;

No

14.2 Will research indemnity be covered? Yes (Please specify: _______) ;

No

15. Recommended Reviewers

15.1 Title: Prof Dr Mr Mdm Ms

Name:

Institution:

Email:


Name:

Institution:

Email:

16. Date of Submission

30

Central Research Working Group


Application Form (For Systematic Review)

PART I: OUTLINE OF APPLICATION

1. Name of Study

1.1 Scientific Title (should include study design, name of intervention, condition being studied

and study outcomes):

1.2 Short Title (for easy quote):

1.3 Is this application for continuation of a project already started?


1.4 Have you applied to other bodies for financial support towards this project?


2. Applicant (Principal Investigator)

2.1 Title: Surname: First Name:

Name in Chinese:

University Staff Position:

Department/ University:

HA Staff Position:

Department/ Hospital:

NGO Staff Position:

NGO:


Appendix II(b)


31

2.2 Qualifications and relevant experience (<500 words)

32

2.3 Phone number:

2.4 Fax number:

2.5 E-mail:

2.6 Mailing address:

3. Co-investigators

Title Surname First Name Post Relevant

Qualifications

Department Institution

4. Milestones

4.1 Proposed study start date: (mm/yyyy)

4.2 Proposed study end date: (mm/yyyy)

33

5. Brief Summary of Study (<1000 words)

34

PART II: STUDY DETAILS

6. Scientific basis

6.1 Disease group (choose from the thematic priorities):

6.2 Background, current evidence and key references:

6.3 Aim of study:

6.4 Data Source:

6.5 Intervention:

6.6 Data Extraction:

7. Anticipated Potential for Research Studies

35

PART III: BUDGET AND USE OF RESOURCES

8. Source of Funding

8.1 NGO: Yes (Please specify: ______________ ) ; No

8.2 University: Yes (Please specify: ______________ ) ; No

8.3 Government: Yes (Please specify: ______________ ) ; No

8.4 Others: Yes (Please specify: ______________ ) ; No

8.5 Amount requested: HKD______________

Staff Cost

Equipment

Others (Please Specify)

Admin Overhead

Total

9. Resources Implication and Conflict of Interest

9.1 Will this study use HA / CMCTR resources? Yes No


9.2 Will study site receive reimbursement for the study? Yes No


9.3 Is there a non-monetary (drug, consumable or equipment) sponsorship?

Yes No


36

10. Recommended Reviewers


Name:

Institution:

Email:


Name:

Institution:

Email:

11. Date of Submission

Chinese Medicine Research Monitoring Report

37

December 2019

Important: Please complete ALL sections with sufficient detail to allow review of the progress of the

research project. Incomplete or insufficiently detailed reports will be returned for revision and resubmission .

The Principal Investigator / Co-Investigator(s) are required to sign the Monitoring Report.

Monitoring Period: 1Q / 2Q / 3Q /4Q/Others: ____ (*Please circle as appropriate)

1. Project Title: _________________________________________________________

2. Study Commencement Date: ___________ Target Completion Date: ____________

3. Study Site(s): (HKE/HKW/KCC/KEC/KWC/NTE/NTW) IRB Approval: Yes/ No

(HKE/HKW/KCC/KEC/KWC/NTE/NTW) IRB Approval: Yes/ No




4. Target Recruitment Number : ___________ Subject(s) Recruited : _____________

5. Principal Investigator:

6. Co-Investigators:

7. Administering Institution:

Appendix III


38 December 2019

8. Aims/Objectives of the Research:

List the main objectives as stated in the approved proposal. Approval must be sought for any

change to the study objectives.

9. Timetable of Work:

Document the study progress according to the proposed timetable.

10. Achievements / Major Findings of the Project in this Quarter:


39 December 2019

11. Clinical Trial Registry:

12. Equipments

Item Name

(e.g. Camera)

Model No.

(e.g. Canon G11)

Warranty

(From – To)

Condition

(Good/Fair/Poor)

1

2

3

4

5

6

7

8

9

10

13. Investigators’ Comments

Describe the potential of further investigations or exploitation of results. May include

reflection/feedback of investigators and/or any difficulties encountered during the course of project.

Comment of the potential for/current dissemination of research findings

www.


40 December 2019

14. Signatures of Project Team

The Principal Investigator / Co-Investigator(s) are required to sign the Monitoring Report . By signing

this Monitoring Report, the Principal Investigator / Co-Investigator(s) (i f any) acknowledge that they have

contributed to the Project and agree with the information contained herein.

Signature of Investigators

Name

Date

1.

2.

3.

4.

5.

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operational guideline for chinese medicine research 醫院管理局

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